Agenda

8th - 9th May 2017

  • 08:00 - 08:45

Registration and Coffee


  • 08:45 - 09:00

Chairperson’s Welcome Address


MARKET ACCESS AND STRATEGIES

  • 09:00 - 09:40

Optimize pricing and market access potentials with RCT and HEOR/RWE

  • Evidence requirements for P&MA globally
  • RCT is the core evidence base
  • RWE plays increasingly important role in Pricing and Reimbursement decisions
  • Early planning is key

Frank Zhang, Head of Global Pricing and Market Access for Immunology and Inflammation, Celgene

  • 09:40 - 10:20

HTA-based models: challenges, complexities and future trends in the US: the presentation will cover the following topics

  • US HTA perspective & Brief overview US HTA system – industry perspective
  • US like HTA process and issues
  • Long-term trends

Clément François, Vice President US, HEOR, Lundbeck

  • 10:20 - 11:00

From Premarket to Postmarket: Developing a Strong Market Access Strategy for Medical Devices

  • Manufacturers should determine the proper classification of their device early in device development
  • Identify a clinical or economic advantage and generate the appropriate clinical and health economic evidence to support a strong value proposition
  • Define the target audience(s) within the market access decision making process. For each target audience, identify whether they are decision-makers or influencers

Nneka Onwudiwe, PRO/PE Regulatory Review Officer, FDA

  • 11:00 - 11:40

Morning Break & Networking


  • 11:40 - 12:20

Global Market Access for Biosimilars and Comparisons with the US Market

  • What are the current biosimilars naming and substitution rules and how will they impact access to biosimilars?
  • Essential MA strategies to ensure appropriate use
  • Which stakeholders to biosimilars and branded biologics manufacturers need to target in their biosimilars education efforts?
  • Regulatory uncertainties
  • Biosimilar Approval Pathways in Europe and the US

Sue Naeyaert, Global Head Pricing, Market Access & Policy Biosimilars, Merck

CHALLENGES AND OPPORTUNITIES

  • 12:20 - 13:00

Cost prediction and decision making for improved patient care

  • Accurate predictions of cost accumulation can be important for patient care delivery and planning.
  • Informed data driven methods can help to identify expected and unexpected factors associated with cost accumulation.
  • Payers, providers, and patients can find the resulting information useful to support healthcare-related decision-making.

Eberechukwu Onukwugha, Associate Professor, University of Maryland

  • 13:00 - 14:00

Networking Lunch


  • 14:00 - 14:40

Real World Evidence within Rare Diseases

John Graham, VP, Head of Value Evidence and Outcomes, GSK
  • 14:40 - 15:20

Market access challenges for (ophthalmology) medical devices

  • Differences in pharma & medical devices access
  • Emerging HTA trends and quality standards
  • Value based tenders in Europe
  • Service and partnerships as alternatives to price discounts
  • Future trends in ophthalmology require innovative access

Miguel Bernabeu, Head of Global Market Access & Government Affairs, Alcon

  • 15:20 - 16:00

Alzheimer’s Disease – Health economic considerations at the advent of the introduction of secondary prevention treatments

  • Alzheimer’s Disease is a devastating, irreversible neurological condition with high socioeconomic burden
  • Novel treatment paradigms in development are geared towards the reduction of amyloid deposition and tau- phosphorylation /aggregation in the brain
  • These treatments are aimed to modify the course of the disease and prevent the onset and speed of cognitive decline
  • As such these disease modifiers have to be given years in advance of the onset of clinical symptoms, necessitating early diagnosis of “at risk” populations
  • The introduction of disease modification drugs can be classified as a secondary prevention approach
  • The presentation will discuss the value proposition for disease modification treatments and the socioeconomic ramifications to payers and society

Frank Wiegand, VP Global Medical Affairs Neurosciences, Janssen

  • 16:00 - 16:40

Tea Break & Networking


  • 16:40 - 17:20

Innovative Engagement Models for Market Access Capabilities

Abdulkadir Keskinaslan, Head Medical Education Latin America & Canada Novartis
  • 17:20 - 18:00

Panel discussion: The future of US Market Access

  • Key challenges in the market access environment
  • Drug access and regulation
  • Payer/manufacturer relationship
  • What lies ahead?

Panelist:
Sheldon Kong, Executive Director, HEOR and Value Evidence, Novo Nordisk

  • 18:00 - 18:10

Chairperson’s Closing remarks


  • 08:30 - 08:45

Registration


  • 08:45 - 09:00

Chairperson’s Opening Remarks


PRICING, REIMBURSEMENT AND PATIENT ACCESS

  • 09:00 - 09:40

Elevating real patient voices to better understand market access, healthcare value frameworks and the patient experience in the cancer context

  • High-light real-world evidence to help define patients perspectives on healthcare value frameworks
  • How the Cancer Support Community used patient-reported data and registries to inform gaps in access to care
  • Understanding patient values and priorities with respect to treatment decision making

Joanne Buzaglo, Senior Vice President, Research & Training, Cancer Support Community

  • 09:40 - 10:20

Public policy, Government relations and Market Access from a Canadian perspective

  • Pricing and Reimbursement in Canada 2017
  • Pan Canadian Pharmaceutical Alliance
  • Patented Medicines Prices Review Board
  • Quebec Tendering Medicines
  • Opportunity for Value Based Pricing in Canada

Terry Creighton, Vice President, Global Public Policy, Teva Pharmaceuticals

  • 10:20 - 11:00

Health Technology Assessment and Reference Pricing - Two sides of the same coin?

  • Many decision makers across the region, with exception of the U.S., have implemented HTA processes to determine reimbursement. Others have relied on imposing pricing regulations, including reference pricing.
  • The impact of these mechanisms is still unclear and decision makers have been using them inconsistently in different countries.

Rafael Alfonso, Lead Evidence Analytics & Innovation, GSK

  • 11:00 - 11:40

Morning Break & Networking


  • 11:40 - 12:20

Current state of affairs and key challenges in market access in US

  • Defining value of pharmaceuticals
  • The emerging role of value frameworks
  • Current pricing debate and its potential impact
  • Can we predict future access in the US and is there a win-win?

Tony Hebden, Vice President, HEOR, Abbvie

DATA COLLECTION AND MANAGAMENT

  • 12:20 - 13:00

Strategies for Advancing BioPharma and Medical Device Market Access in the era of Value Based Care

  • Embracing a broader set of quality measures in new payment models
  • Enhanced health economic evidence/data availability, transparency and integration
  • Extension of the definition of unmet need to address gaps in clinical processes and financial goals
  • Adoption of risk-sharing models that aligns goals and incentives of diverse decision makers

Shelly Ikeme, Global Head of Market Access, Baxter International

  • 13:00 - 14:00

Networking Lunch


  • 14:00 - 14:40

Value or Cost: Content relevance to differencing Health care systems

  • Value as a perception, what does it mean of differing health care systems (key Global markets)
  • Is there a disconnect been value and price
  • How are we in Health care and Pharma perceived
  • Are we making tradeoff to equilibrate value to circumvent price
  • At what Value or Cost, will we allow Access and ensure Reimbursement
    Conclusions and suggestions

Arup Pramanik – VP, Global Head, Patient Access & Advocacy, former Shire

COLLABORATION AND LOOKING TO THE FUTURE

  • 14:40 - 15:20

Agreements and collaboration

  • Risk sharing agreements: incorporating financial models with performance based/outcomes based models
  • How to find the right partner?
  • In licensing and out licensing

  • 15:20 - 16:00

Tea Break & Networking


  • 16:00 - 16:40

Value Frameworks for Health Technology Assessment and Market Access in the United States

  • Review examples of recently created Value Frameworks (e.g., Drug Abacus from Memorial Sloan Kettering Cancer Centre, Institute for Clinical and Economic Reviews Value Assessment Framework)
  • What is the role of patient’s preferences? (Faster Cures’s Patient Perspective Value Framework)
  • Methodology considerations for conducting Value Assessments

Kevin Mayo, Global Hemophilia Franchise Market Access Head, former Baxalta

  • 16:40 - 17:20

Panel discussion: Key industry trends

  • Patient centricity
  • Collaborations, mergers and acquisitions
  • Healthcare Reform

Panelist:
Juan Camilo Roman, Senior Director, Global MA HCV/Specialty, AbbVie*
Peter Vanovertveld, Head Global Value Strategy & Access, Shire*
Tehseen Salimi, TA Vice President in Global Medical Affairs, AstraZeneca

  • 17:20 - 17:30

Chairperson’s Closing remarks